A Pilot study examining the Neurobiological correlates of Virechanakarma in Patients with Major Depressive Disorder
Trial Snapshot
- Phase
- Phase 3 4
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- To examine the baseline Cardiac Autonomic Function & Neurohemodynamic
Study Overview
Brief Summary
Depression is the most common psychiatric disorder in the world population and the most
frequent mental disorder in a primary health care. Depressive disorders are characterized by
sadness, loss of interest or pleasure, feelings of guilt or low self-worth, disturbed sleep or
appetite, feelings of tiredness, and poor concentration. Major depressive disorder (MDD) is
analogous to a disease condition described in Ayurveda as Vishada. Vishada is a condition
characterized by global reduction in activities of mind, sensory faculties and body arising out of
disequilibria in doshas. Vishada has been mentioned as an extraordinary disease of the vata.
Ayurveda literature has dealt with the disease and its management comprehensively. Clinically
apart from vata dosa , involvement of kapha & pitha are also seen in patients of Major depressive
disorders like reduced energy levels , increased fatiguability , loss of appetite , diurnal variation
of worsening in morning hours ,dullness , withdrawal , disgust , anxiety etc,. In the combination
of tridosa, kapha need to be addressed first, then pitha and then vata. For kaphapitha hara
virechana is the best sodhana therapy advised as per Ayurveda literature. Recent study
demonstrates a positive influence of ayurvedic therapy on psychopathology, cardiac autonomic
function and endocrinal parameters in patients with depression. Clinically, we have found
considerable improvement in mood symptoms after a course of sodhana therapy. Sodhana can be
an adjunct in treating mood disorders. No published literature on efficacy of virechana in Mood
disorders are there, despite being classically recommended in texts. Neurobiological correlates of
virechanakarma in neuropsychiatric disorders is not studied making it a novel effort. Hence, this
study aims to understand the neurobiological correlates of virechanakarma in patients with
MDD.
It is a randomised control trial study which will assess changes in clinical parameters, cardiac
autonomic function(HRV), neurohemodynamic parameters(fNIRS), physiological
parameters(CRP , S.Cortisol) and metabolic parameters(FBS & Lipid profile) after the
intervention.
Study Design
- Study Type
- Interventional
- Allocation
- Permuted block randomization, fixed
- Masking
- Participant Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Between 18 to 60 years of age.
- •All genders.
- •Diagnosed case of unipolar depression as per DSM 5
- •Patients who have not responded (Subjective improvement less than 50% / HDRS scale less than 50% reduction in score / CGI – severity score more than or equal to 4 or CGI global improvement score at the end of 4 weeks is more than or equal to 3) to 4 weeks of first Antidepressant trial.
- •Patients suitable for Virechana
- •Willing to give informed consent.
Exclusion Criteria
- •Patients who are on Tricyclic Antidepressants
- •Patients with any co -morbid axis I psychiatry disorders (except for nicotine dependence syndrome), major systemic illness, neurological disorders and immune systemdisorders
- •Patients with active suicidal tendencies / attempts or uncooperative for assessments and procedure
- •Pregnant and lactating mothers
- •Patients unsuitable for Virechana procedure
- •Patients with uncontrolled diabetes mellitus, hypertension, severe hepatic, renal or pulmonary dysfunction
- •Patients who have undergone Virechana in the last 1 month.
Outcomes
Primary Outcomes
To examine the baseline Cardiac Autonomic Function & Neurohemodynamic
Time Frame: Baseline, 2 weeks
parameters in patients with MDD in comparison to Healthy people by measuring
Time Frame: Baseline, 2 weeks
HRV & fNIRS of Dorsolateral Prefrontal Cortex.
Time Frame: Baseline, 2 weeks
• To examine the change in Cardiac Autonomic Function & Neurohemodynamic
Time Frame: Baseline, 2 weeks
parameters following add-on virechanakarma in patients with MDD in comparison
Time Frame: Baseline, 2 weeks
to Treatment As Usual Group (TAU)
Time Frame: Baseline, 2 weeks
Secondary Outcomes
- To examine the clinical effects of add-on virechanakarma in patients with MDD in(comparison to Treatment As Usual Group (TAU).)
